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Subject Matter Expert Biophysical Analysis (Associate Principal Scientist) Netherlands,  

Posted on : 04 June 2017

Project Description

Subject Matter Expert Biophysical Analysis (Associate Principal Scientist)-BIO004841DescriptionThe departmentThe Biologics & Vaccines Analytics (BVA) organisation supports the commercialization of vaccines and biotechnological derived pipeline products. Furthermore, BVA has a crucial role in supporting vaccines and biologics Lines of Business (LoB) and the Quality Organization. As part of the BVA organization analytical and process Centers of Excellence are located in the US and Oss, The Netherlands. These teams are regionally responsible for support to LoB and Quality and introducing new processes and analytical methods into the commercial operations space.The positionReporting into the Team Lead SME s the Subject Matter Expert Biophysical Analysis oversees all biophysical characterization efforts from a scientific perspective and is able to translate current thinking and new advances into our analytical portfolio. In that role the person establishes and maintains an internal and external network of biophysical experts. Furthermore he or she indirectly guides all biophysical related activities in the department and provides significant input into regulatory documents and response to questions. This position does not have direct reports.Roles and responsibilities include:Scientific and Technical leadership (60% of average time spent) " Analytical SME, with deep scientific understanding of biophysical methods (CD, FTIR, Fluorescence spectroscopy, DSC, SEC-MALLS, AUC, DLS, MFI) used for characterizing biotechnological products, e.g. protein structure, protein aggregates and particulates; " Responsible for best scientific practices within the lab space and supports from an extended characterization perspective troubleshooting, process support and life cycle management activities; " Writes complex technical documentation used for regulatory filings (e.g. Justification of specifications, process characterization summaries); " Recruitment and supervision of MSc-level students.Project leadership (40% of average time spent) " Participates in cross-functional/global CMC project teams and leads derived subteams (e.g. working groups responsible for analytical or drug substance development workstreams); " Participates as SME in solving technical problems at an international level; " Root Cause Analysis lead for significant investigations (regional).QualificationsDesired skills & experience " PhD in biological sciences, biochemistry, or biochemical engineering or equivalent through experience; " Minimum of 5-10 years relevant experience in protein analytics; " Significant experience in analytical methodologies for quality control of biotechnological products; " Strong project management skills & proven ability to manage complex projects; " Knowledge of regulatory and quality guidelines, and knowledge on CTD format for IND/ BLA/ MAA submissions preferred; " Excellent analytical and technical skills; " Demonstrated initiative, and innovative process-oriented thinking within a team environment; " Excellent oral and written communication skills in English (Dutch is a plus).About MSDMSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.MSD. Be well. For more information, visit our website: www.werkenbijmsd.nlA good place to workOur employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.Information:For more information about this position you can contact Joop Waterval, Principal Scientist, by phone via 0031 (0)412-661884.ApplicationIf you are interested in this challenging role, you are requested to apply online by uploading your resume and application letter in English.Recruitment Agency / Search Firm representatives please note:MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.Job: Biologics, Vaccines, Analytical Formulat Job Title:Subject Matter Expert Biophysical AnalysisPrimary Location: EMEA-Netherlands-NB-OssEmployee Status: RegularTravel: NoNumber of Openings: 1Company Trade Name:MSD Job Segment: Scientific, Biochemistry, Law, Engineer, Scientist, Engineering, Science, Legal


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